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Boston Scientific Corporation: ENDOTAK RELIANCE G/SG with 4-SITE Connector,

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall reason: Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.. Recalled by Boston Scientific Corporation. Distribution: Worldwide Distribution. US nationwide. International distribution worldwide.. Classification (Class I — serious health hazard). Affected lots/dates: Model 0282 UDI-DI/GTIN 00802526431371; Model 0283 UDI-DI/GTIN 00802526431388 00802526504181; Model 0285 UDI-DI/GTIN. Contact the manufacturer or the retailer where you purchased this device to arrange for a free correction, re

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer
Category Product Recalls & Refunds
Location National
Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.
Source Official Source ↗
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